Regulatory Focus™ > News Articles > 2021 > 4 > Recon: EMA says 'possible' AZ-blood clot link; Invitae's $1.2B gene testing investment

Recon: EMA says 'possible' AZ-blood clot link; Invitae's $1.2B gene testing investment

Posted 07 April 2021 | By Kari Oakes 

Recon: EMA says 'possible' AZ-blood clot link; Invitae's $1.2B gene testing investment

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • U.S. begins study on allergic reaction risk in Moderna, Pfizer vaccines (NIH) (Reuters)
  • CDC says variant from the UK is now the most common strain circulating in the U.S. (CNBC)
  • U.S. delivering about 3 million COVID-19 vaccines per day, up 8%: CDC director (Reuters)
  • U.S. surpasses 150 million vaccine shots under Biden, on track to hit President’s new 200 million shots goal (CNBC)
  • ‘A moment of peril’: Biden’s coronavirus response collides with case spikes (WaPo)
  • Hospitals are seeing more young adults with severe Covid symptoms, CDC says (CNBC)
  • J&J vaccine-maker’s troubles started months ago (Politico)
  • Exit Interview: Abernethy Tells Why She’s Leaving FDA – But Staying on Her Own Path (MedTech Insight)
In Focus: International
  • U.K. says AstraZeneca alternative should be offered for under 30s, and E.U. finds a ‘possible link’ to rare clots (NYT) (EMA) (Reuters) (STAT) (WaPo) (MHRA)
  • EU drug regulator: 169 cases of rare brain blood clot out of 34 million AstraZeneca doses in region (Reuters)
  • Some Indian states warn of vaccine shortage as COVID-19 cases peak (Reuters)
  • Can the UK Remain A First Launch Market? (Pink Sheet)
  • ICER reviews price of new multiple myeloma treatments (Pharmaletter)
  • TGA to review advertising of stem cell therapies to the Australian public (TGA)
Coronavirus Pandemic
  • Brazil detects first case of South African variant as COVID-19 deaths soar (Reuters) (NPR)
  • Scientists call for new probe into COVID-19 origins: with or without China (Reuters)
  • Benefits of AstraZeneca vaccine outweigh risks: Swedish Medical Products Agency (Reuters)
  • Covid-19 reinfections are rare — but without better data, we don’t how rare (STAT)
  • UK begins rollout of Moderna COVID-19 vaccine (Pharmafile)
  • Drugs Targeting Immune Response To COVID-19 Show Promise (NPR)
  • The Personal Toll of Working Around the Clock at the Onset of a Global Pandemic (MD+DI)
  • Meet The 40 New Billionaires Who Got Rich Fighting Covid-19 (Forbes)
Pharma & Biotech
  • The Endpoints 100 survey: CEOs changed the way biotechs operate during the pandemic. Things will never be the same again (Endpoints)
  • U.S. FDA extends review of Pfizer's experimental skin disease drug (Reuters) (Fierce)
  • Nuplazid Complete Response Letter For Dementia Psychosis Driven By Effectiveness Concerns In Subgroups (Pink Sheet)
  • Roxadustat CKD Doubts Fanned By FibroGen Data Blunder (Scrip) (Biopharma Dive)
  • Pfizer unveils its oral SARS-CoV-2 inhibitor (C&EN)
  • Five Phase III Data Readouts To Look Out For In Q2 (Scrip)
  • Icosavax keeps up the excitement for its VLP 'soccer balls,' earning the RA Capital stamp of approval in $100M Series B (Endpoints) (Fierce)
  • BRIEF—EC green light for new subcutaneous Tysabri for MS (Pharmaletter)
  • Novartis taps DNA damage specialist Artios in $1.3B discovery deal to complement growing radioligand portfolio (Endpoints)
  • Scholar Rock Reports Positive Topline Results from Therapy for SMA Types 2 and 3 (Global Genes)
  • New group to tackle data governance and guide digital transformation in pharma (EPR)
  • Sanofi Global Health set up to provide 30 essential meds to poorest countries (Pharmaletter)
  • David Davidson’s R&D odyssey takes him out of bluebird to another biotech startup (Endpoints)
  • Invitae inks $200M Genosity buyout, lands $1.2B investment to expand genetic testing (Medtech Dive)
  • Bayer-backed Metagenomi bumps up series A to $75M as it gears up for gene editing push (Fierce)
  • Akili’s therapeutic video game will be tested as a treatment for Covid ‘brain fog’ (STAT) (Pharmaletter)
  • NHS roll out gadget for cluster headaches (MobiHealthNews)
  • Is ‘Femtech’ the Next Big Thing in Health Care? (NYT)
  • AstraZeneca's Amaze platform aims to simplify chronic disease management—and put patients and docs on same page (Fierce)
  • Digital health funding hits new high after Q1 rich in megadeals (MedTech Dive)
  • A conversation on artificial intelligence and gender bias (McKinsey)
Government & Regulatory
  • The continuing CRISPR patent saga (Endpoints)
  • Merck reaches deal with Austrian antitrust regulators over ‘predatory’ pricing for a cancer drug (STAT)
  • Regulatory considerations, challenges and risk-based approach in nanomedicine development (PubMed)
  • J&J scores backing from Chamber of Commerce, PhRMA and more in Supreme Court appeal of $2.1B talc verdict (Fierce Pharma)
  • Suit alleging Medtronic misled FDA over spine fusion can proceed, appeals court says (MedTech Dive)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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